MAUDE Adverse Event Report: CORCYM CANADA CORP PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS21

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Thrombocytopenia (4431)

Event Date 11/09/2020

Event Type  Death  

Manufacturer Narrative

Unknown if explanted (autopsy performed).

Event Description

On (b)(6) 2020, a perceval valve pvs21 was indwelled with a midline incision on (b)(6) 2020, in combination with cabg.The preoperative platelet count was 195,000.On the day of surgery, 20 units of platelets were transfused.On the same day, the patient underwent reopen-chest hemostasis.The day after the operation, the platelet count was 31,000.20 units were transfused.On the 4th day after the operation, the platelet count was 22,000.20 units were transfused.Seven days after the operation, the platelet count was 29,000.20 units were transfused.The patient underwent multiple surgeries, including reopen-chest hemostasis and mediastinitis surgery, eventually transfusing a total of 150 units of platelets.This person has passed away of multiple organ failure (date unknown).The minimum platelet count is 8,000.Additional details obtained from the surgeon indicated the following: this patient had a lower extremity obstruction during surgery, so heparin was used.Therefore, the patient had bleeding and underwent reopen-chest.There was no causal relationship between a large amount of platelet transfusion and perceval valve.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.

Manufacturer Narrative

Fields updated: b4, d3, g1, g3, g6, h1, h2 (selected as additional information as placeholder, no actual additional information has been received to date).Because the device remains implanted no additional investigations are possible at this time.The manufacturer attempted to retrieve additional information but none was provided to date.Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Given the medical judgment received confirming that there was no causal relationship between a large amount of platelet transfusion and perceval valve, the device can be excluded as a contributory cause to the event of postoperative thrombocytopenia.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11389742
• MDR Text Key: 233945579
• Report Number: 3004478276-2021-00130
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230123
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 83 YR
• Patient Weight: 56